Table 5 Standards for reporting diagnostic accuracy studies checklist [12] (2015 version)
Section & Topic | No | Item | On page & line |
|---|---|---|---|
Title or Abstract | 1 | Identification as a study of diagnostic accuracy using at least one measure of accuracy (such as sensitivity, specificity, predictive values, or AUC) | P6 L2 |
Abstract | 2 | Structured summary of study design, methods, results, and conclusions | P2 |
Introduction | 3 | Scientific and clinical background, including the intended use and clinical role of the index test | P4 |
4 | Study objectives and hypotheses | P5 L9 | |
Methods | |||
Study design | 5 | Whether data collection was planned before the index test and reference standard were performed (prospective study) or after (retrospective study) | P7 L5 |
Participants | 6 | Eligibility criteria | P7 L5 |
7 | On what basis potentially eligible participants were identified (such as symptoms, results from previous tests, inclusion in registry) | P7 L5 | |
8 | Where and when potentially eligible participants were identified (setting, location and dates) | P7 L5 | |
9 | Whether participants formed a consecutive, random or convenience series | P7 L5 | |
Test methods Analysis | 10a | Index test, in sufficient detail to allow replication | P8 L13 |
10b | Reference standard, in sufficient detail to allow replication | P7 L10 | |
11 | Rationale for choosing the reference standard (if alternatives exist) | P8 L13 | |
12a | Definition of and rationale for test positivity cut-offs or result categories of the index test, distinguishing pre-specified from exploratory | P8 19 | |
12b | Definition of and rationale for test positivity cut-offs or result categories of the reference standard, distinguishing pre-specified from exploratory | P8 L19 | |
13a | Whether clinical information and reference standard results were available to the performers/readers of the index test | P8 L19 | |
13b | Whether clinical information and index test results were available to the assessors of the reference standard | P8 L20 | |
14 | Methods for estimating or comparing measures of diagnostic accuracy | P9 L3 | |
15 | How indeterminate index test or reference standard results were handled | N/A | |
16 | How missing data on the index test and reference standard were handled | N/A | |
17 | Any analyses of variability in diagnostic accuracy, distinguishing pre-specified from exploratory | N/A | |
18 | Intended sample size and how it was determined | N/A | |
Results | |||
Participants | 19 | Flow of participants, using a diagram | Fig. 1 |
20 | Baseline demographic and clinical characteristics of participants | N/A | |
21a | Distribution of severity of disease in those with the target condition | N/A | |
21b | Distribution of alternative diagnoses in those without the target condition | P11 L21 | |
22 | Time interval and any clinical interventions between index test and reference standard | N/A | |
Test results | 23 | Cross tabulation of the index test results (or their distribution) by the results of the reference standard | |
24 | Estimates of diagnostic accuracy and their precision (such as 95% confidence intervals) | ||
25 | Any adverse events from performing the index test or the reference standard | ||
Discussion | |||
26 | Study limitations, including sources of potential bias, statistical uncertainty, and generalisability | P15 L19 | |
27 | Implications for practice, including the intended use and clinical role of the index test | P17 L3 | |
Other Information | 28 | Registration number and name of registry | N/A |
29 | Where the full study protocol can be accessed | P17 L8 | |
30 | Sources of funding and other support; role of funders | P17 L8 | |